Conception of a Decisional Tool Using a Pre-Anesthesic Numerical Evaluation (PANE) During the 8th Month of Pregnancy (PANE)

Validation of a New Tool for a Numeric Pre-anesthesic Evaluation for Pregnant Women During Their Pregnancy Follow-up in University and Regional Maternity of Nancy (France)

In France, all pregnant women benefit from an pre-anesthesic consultation (PAC) to evaluate their physical and biological conditions.

Many of pregnant women are healthy, there is only on type of induction protocol in case of general anesthesia, they are all at risk of difficult intubation and blood samples are already performed by obstetricians.

Thus, investigators' hypothesis is that for many pregnant women, an alternative pre-anesthesic evaluation, other than the classic 8th month PAC is possible. So, the investigators would create a tool able to perform a women's triage, and to detect which of them have to see an anesthesist during a face-to-face consultation and which of them could do without it.

Investigators' study will be about the monocentric analysis of a pre-anesthesic numerical evaluation with the aid of a questionnaire, vouched for by an experts committee specialized in obstetrical anesthesia.

Study Overview

• Status: Unknown
• Conditions: Pregnancy Related
• Intervention / Treatment: Other: Pre-Anesthesic Consultation; Other: Pre-Anesthesic Numerical Evaluation

Detailed Description

Every month, several thousands of women benefit from an obstetrical pre-anesthesic consultation (PAC) in France, during their 8th month of pregnancy. It is the opportunity to evaluate women's physical and biological conditions before their delivery.

This consultation is mandatory in France. It must be carried out by an anesthesist and should aim at proposing an analgesic and anesthesic strategies as well as relaying all the resulting information to the patients.

A study carried out in 2015 in two Parisian 3rd level maternity hospitals showed that the majority of women seen in obstetrical PAC are healthy. A preliminary observational, prospective and multicentric study in 20 Lorraine (France) maternity hospitals was implemented in order to identify more specifically the population of women seen during this consultation. Despite of a probable under-estimation, investigators' results showed 40,3% of women ASA 1, with a physiologic pregnancy, without hemostasis disorder and planned for a vaginal delivery.

With these healthy women, according to the recommendations of the French Society of Anesthesia and Intensive Care (SFAR) edited in 2012 and those of the French Health Authority (HAS) edited in 2016, the only obligatory biological exam for the anesthesic care is the 6th month blood count (with blood type and irregular antibodies).

Despite those recommendations, over-prescription of biological tests during the preoperative clinic in pre-partum persists (in the investigators' study, they found a probable under-estimated number of 34,5% unjustified prescriptions).

Moreover, the PAC aims at evaluating superior airways, for the purpose of a potential oro-tracheal cannulation in case of general anesthesia. However, this evaluation had a relative interest in this context considering that the superior airways anatomy changes during pregnancy and labor and all pregnant women must all be considered at risk of difficult intubation.

In addition, all pregnant women from 20 weeks of amenorrhea are considered as full stomach. Thus, in case of general anesthesia, the investigators have to perform a crash induction. So, there is no other protocol of induction to consider in this context.

Regardless of the context, pregnant women see an anesthesist before their delivery during the pre-anesthesic visit : the sooner 24 hours before an intervention, at the latest when they arrive in the delivery room.

Actually, society is faced with important problems of medical demography and anesthesists are less and less numerous, making their activity more and more difficult.

Investigators' hypothesis is that for the population of pregnant healthy women, an alternative pre-anesthesic evaluation, other than the classic 8th month PAC, could be an innovative idea for health system, ensuring care quality and security of pregnant women.

The investigators would create a new tool able to perform a women's triage, and to detect which of them have to see an anesthesist during a face-to-face consultation and which of them could do without it.

Those types of pre-anesthesic evaluations have already been tested in other countries. A controlled randomized study, executed in Australia between 2012 and 2013, showed the feasibility of a non "in-person" evaluation (by phone, with the aid of an informatic tool and a anesthesist proofreading). Considering these results, the investigators think that it is possible to transpose this type of evaluation to the obstetrical field.

Investigators' study will be about the monocentric analysis of a pre-anesthesic numerical evaluation with the aid of a questionnaire, vouched for by an experts committee specialized in obstetrical anesthesia.

Ultimately, investigators' ambition is to carry out a national multicentric study to analyze this tool on a larger scale.

• Study Type: Observational
• Enrollment (Anticipated): 336

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The study population is the women who benefit from a classical pre-anesthesic consultation in maternity hospital of Nancy.

Description

Inclusion Criteria:

• Major women profiting of a planned pre-anesthesic consultation
• Women who received complete information on research management and who didn't refuse to her participation and her data use.

Exclusion Criteria:

• Participation refusal
• Women without liberty because of a legal or administrative decision
• Women who benefit of psychiatric cares
• Underage women
• Women with legal protection (ex : guardianship)
• Women who can't express their consent
• Language barrier
• Precarious social situation
• Medical pregnancy interruption, foetal death in utero

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PANE -> PAC; First, the patient carry out her Pre-Anesthesic Numerical Evaluation and then she benefits from her Pre-Anesthesic Consultation.	Other: Pre-Anesthesic Consultation; Classical Pre-Anesthesic Consultation with an anesthesist of the maternity hospital of Nancy (France); Other: Pre-Anesthesic Numerical Evaluation; Home-based Pre-Anesthesic Numerical Evaluation with the aid of a questionnaire, achieved with a computer, digital tablet or smartphone, on a secured platform.
PAC -> PANE; First, the patient benefits from her Pre-Anesthesic Consultation and then, she carry out her Pre-Anesthesic Numerical Evaluation	Other: Pre-Anesthesic Consultation; Classical Pre-Anesthesic Consultation with an anesthesist of the maternity hospital of Nancy (France); Other: Pre-Anesthesic Numerical Evaluation; Home-based Pre-Anesthesic Numerical Evaluation with the aid of a questionnaire, achieved with a computer, digital tablet or smartphone, on a secured platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validated Pre-Anesthesic Numerical Evaluation questionnaire	Conception of a new and numerical tool for the obstetrical pre-anesthesic evaluation of pregnant women during their pregnancy follow-up. This conception will contain, first, the creation of the questionnaire and then the assessment of the questionnaire's effectiveness in a monocentric study.	Before enrollment of first pregnant women and during pre-anesthetic consultation of the 8th month.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elaborate and validate the first version of Pre-Anesthesic Numerical Evaluation questionnaire	Using the French Health Authority's method published in 2010 : " Recommendations by formalized consensus", validation of the questionnaire with the aid of an experts committee specialized in obstetrical anesthesia.	Before enrollment of first pregnant women
Validate the first version of Pre-Anesthesia Numerical Evaluation within the population of pregnant women of Maternity Hospital of Nancy (France)	Compare the 8th month pre-anesthesic evaluation realized during the classical pre-anesthesic consultation in comparison with the new tool of pre-anesthesic numerical evaluation. The comparison will be proceed thanks to a composite endpoint including birth mode : vaginal delivery or caesarean.	During pre-anesthetic consultation of the 8th month
Validate the first version of Pre-Anesthesia Numerical Evaluation within the population of pregnant women of Maternity Hospital of Nancy (France)	Compare the 8th month pre-anesthesic evaluation realized during the classical pre-anesthesic consultation in comparison with the new tool of pre-anesthesic numerical evaluation. The comparison will be proceed thanks to a composite endpoint including American Society of Anesthesiologists (ASA) score : 1 (better outcome), 2, 3, 4 or 5.	During pre-anesthetic consultation of the 8th month
Validate the first version of Pre-Anesthesia Numerical Evaluation within the population of pregnant women of Maternity Hospital of Nancy (France)	Compare the 8th month pre-anesthesic evaluation realized during the classical pre-anesthesic consultation in comparison with the new tool of pre-anesthesic numerical evaluation. The comparison will be proceed thanks to a composite endpoint including existence of bleeding diathesis : Yes or No.	During pre-anesthetic consultation of the 8th month
Validate the first version of Pre-Anesthesia Numerical Evaluation within the population of pregnant women of Maternity Hospital of Nancy (France)	Compare the 8th month pre-anesthesic evaluation realized during the classical pre-anesthesic consultation in comparison with the new tool of pre-anesthesic numerical evaluation. The comparison will be proceed thanks to a composite endpoint including existence of non-physiologic pregnancy : physiologic pregnancy or non-physiologic pregnancy.	During pre-anesthetic consultation of the 8th month

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Hervé Bouaziz, MD, PhD, Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: December 27, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 10, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Pregnancy
• Other Study ID Numbers: 2019PI140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No